FOSFOMICIN CALCIUM SOLUFOS 500 mg HARD CAPSULES

Introduction

Patient Information Leaflet

Fosfomycin Calcium Solufos 500 mg Hard Capsules

Fosfomycin Calcium

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet:

1. What Fosfomycin Calcium Solufos is and what it is used for
2. What you need to know before taking Fosfomycin Calcium Solufos
3. How to take Fosfomycin Calcium Solufos
4. Possible side effects
5. Storage of Fosfomycin Calcium Solufos

Package Contents and Additional Information

1. What Fosfomycin Calcium Solufos is and what it is used for

Fosfomycin Calcium Solufos contains the active ingredient fosfomycin (as fosfomycin calcium). It is an antibiotic that works by eliminating the bacteria that can cause infections.

Fosfomycin Calcium Solufos is used to treat uncomplicated bladder infections in women.

2. Before taking Fosfomycin Calcium Solufos

Do not take Fosfomycin Calcium Solufos

• if you are allergic (hypersensitive) to fosfomycin or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Fosfomycin Calcium Solufos if you are in any of the following situations:

• you have persistent bladder infections,
• you have ever had diarrhea after taking any other antibiotic.

Symptoms to Watch Out For

Fosfomycin Calcium Solufos may cause serious side effects. For example, allergic reactions and inflammation of the large intestine. You should pay attention to certain symptoms while taking this medication to reduce the risk of problems. See "Serious Side Effects" in section 4.

Children and Adolescents

This medication should not be given to children under 12 years of age, as its safety and efficacy have not been established in this age group.

Other Medications and Fosfomycin Calcium Solufos

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription.

This is especially important if you are taking:

• metoclopramideor other medications that increase the movement of food through the stomach and intestines, as they may reduce the absorption of fosfomycin in your body,
• anticoagulants, as fosfomycin and other antibiotics may alter your ability to prevent blood clotting.

Taking Fosfomycin Calcium Solufos with Food and Drinks

Food may delay the absorption of fosfomycin. Therefore, this medication should be taken on an empty stomach (2-3 hours before or 2-3 hours after a meal).

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant or breastfeeding, your doctor will only prescribe this medication when it is strictly necessary.

Driving and Using Machines

You may experience side effects, such as dizziness, that could affect your ability to drive or use machines.

3. How to Take Fosfomycin Calcium Solufos

Follow the exact instructions for administration of this medication indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

For the treatment of uncomplicated bladder infections in women, the recommended dose is 500 mg-1 g (1 or 2 capsules) every 8 hours.

Use in Patients with Renal Impairment

This medication should not be used in patients with severe renal impairment (creatinine clearance <10 ml min).< p>

Use in Children and Adolescents

This medication should not be used in children under 12 years of age.

Method of Administration

For oral use.

This medication should be taken orally, on an empty stomach (approximately 2-3 hours before or 2-3 hours after a meal), with the last dose preferably taken before bedtime and after urination.

If You Take More Fosfomycin Calcium Solufos Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If You Forget to Take Fosfomycin Calcium Solufos

Do not take a double dose to make up for missed doses.

If you miss a dose, take the next one as soon as possible and continue as before.

If You Interrupt Treatment with Fosfomycin Calcium Solufos

Remember to take your medication. Your doctor will indicate the duration of your treatment with Fosfomycin Calcium Solufos. Do not interrupt treatment, even if you feel better, unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Serious Side Effects

If you experience any of the following symptoms during treatment with Fosfomycin Calcium Solufos, stop taking the medication and contact your doctor immediately:

• anaphylactic shock, a potentially life-threatening allergic reaction (frequency not known). Symptoms are sudden onset of a rash, itching or hives, and/or shortness of breath, wheezing (whistling sound when breathing) or difficulty breathing,
• swelling of the face, lips, tongue, or throat with difficulty breathing (angioedema) (frequency not known),
• moderate to severe diarrhea, abdominal cramps, bloody stools, and/or fever, which may indicate that you have a large intestine infection (antibiotic-associated colitis) (frequency not known). Do not take medications that stop intestinal movement (antiperistaltics).

Other Side Effects

Common (may affect up to 1 in 10 people):

• headache
• dizziness
• diarrhea
• nausea
• indigestion
• abdominal pain
• infection of the female genital organs with symptoms such as inflammation, irritation, itching (vulvovaginitis).

Uncommon (may affect up to 1 in 100 people):

• vomiting
• rash
• hives
• itching

Rare (may affect up to 1 in 1,000 people):

• anemia
• overinfections with antibiotic-resistant bacteria

Frequency not known (cannot be estimated from available data):

• allergic reactions
• visual disturbances
• loss of appetite
• inflammation of the veins
• increased white blood cell and platelet count
• appearance of petechiae (small bleeding spots on the skin)
• alteration of liver enzymes

If you experience any of these reactions or other discomforts that you think are related to treatment, inform your doctor as soon as possible.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fosfomycin Calcium Solufos

Keep this medication out of sight and reach of children.

Do not use Fosfomycin Calcium Solufos after the expiration date stated on the packaging, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be thrown away down the drain or in the trash. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Additional Information

Composition of Fosfomycin Calcium Solufos

• The active ingredient is fosfomycin.

Each capsule contains 500 mg of fosfomycin in the form of calcium salt.

• The other components are: polyethylene glycol 6000, sodium docusate, gelatin, red iron oxide (E-172), erythrosine (E-127), and titanium dioxide (E-171).

Appearance of the Product and Package Contents

Fosfomycin Calcium Solufos 500 mg hard capsules are presented in oral capsule form in packages containing 12 and/or 24 units.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Q pharma S.L.

C/ Portugal Entlo. C.

03003 Alicante. Spain

Manufacturer

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2

28108 Alcobendas (Madrid). Spain.

Date of the Last Revision of this Leaflet: October 2021

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/